Nutrient Fortified Oat Drink

August 16, 2011 updated by: PepsiCo Global R&D

The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children

This study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Philippines
      • Taguig City, Philippines
        • Recruiting
        • FNRI
        • Contact:
          • Angeles-Agdeppa
          • Phone Number: 2280 011-63-2-8372071
        • Principal Investigator:
          • Imelda Angeles-Agdeppa, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 5-7 years old
  • Children with parental consent
  • Not suffering from diarrhea, respiratory infections and fever at time of interview and for the past two weeks
  • No history of blood disorder or malaria
  • Had not participated in any feeding program for the past 4 months
  • Children with Hb > 70 g/L to <120 g/L (WHO/UNICEF/UNU, 1998)
  • CRP <10 mg/L

Exclusion Criteria:

  • All children aged < 5 years old and > 7 years old
  • Without parental consent
  • Undergoing treatment for any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at the time of examination or during the past two weeks.
  • Reported current or history of blood abnormalities/hemoglobinopathies
  • Children with all normal Hb levels or very low Hb < 70 g/L
  • CRP >10mg/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Other: Dietary Intervention
Nutrient fortified oat beverage
Experimental: Nutrient Fortified Beverage
Other: Dietary Intervention
Nutrient fortified oat beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Iron status: Change in hemoglobin and serum ferritin
Time Frame: Baseline and 4 months
Baseline and 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
zinc, vitamin A and vitamin C status
Time Frame: Baseline and 4 months
Baseline and 4 months
Weight, height, CRP and frequency of illness
Time Frame: Baseline and 4 months
Baseline and 4 months
Dietary intake
Time Frame: Baseline and 4 months
Baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Collaborators

PepsiCo - Philippines

Investigators

  • Principal Investigator: Imelda Angeles-Agdeppa, PhD, FNRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (Estimate)

August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

August 17, 2011

Last Update Submitted That Met QC Criteria

August 16, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP 1011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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